Indications and uses
■ temporarily relieves the following cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ cough■ stuffy nose ■ sneezing and runny nose ■ temporarily reduces fever
DrKids Children Multi Symptom Cold and Flu
- Manufacturer
- Calmco
- Effective date
- 2023-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:11:23
Label at a glance#
ProductDrKids Children Multi Symptom Cold and Flu
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE
Label structure8 sections
Dosage and administration
■ this product does not contain directions or complete warning for adult use ■ do not give more than directed (see overdose warning) ■ find right dosage on chart below ■ empty each Single-Use Vial of all liquid when dosing, following the instructions under "Easy to use" on the side panel ■ repeat dose every 4 hours while symptoms last ■ do not give more than 5 times in 24 hours ■ children under the age of 6, do no...
Contacts and useful links#
Websitewww.drkids.com
www.drkids.com
www.drkids.comLabel contents#
Full prescribing information#
Active Ingredient (in each 10mL)
Acetaminophen, 320mg
Chlorpheniramine Maleate, 2mg
Dextromethorphan HBr, 10mg t
Phenylephrine HCl, 5mg
Purpose
Pain reliever / fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Uses
■ temporarily relieves the following cold/flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ cough■ stuffy nose
■ sneezing and runny nose ■ temporarily reduces fever
Warnings
Liver Warning: this product contains acetaminophen. Severe liver damage may occur if your child takes
■ more than 5 doses in 24 hours, which is the maximum daily amount for this product
■ with other drugs containing acetaminophen.
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
■ to make a child sleepy
■ in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
■ if your child has is allergic to any of the ingredients in this product
Ask a doctor befre use if your child has
■ liver disease ■ high blood pressure ■ heart disease ■ diabetes ■ thyroid disease ■ glaucoma ■ a breathing problem such as chronic bronchitis ■ persistent or chronic cough such as occurs with asthma ■ cough that occurs with too much phlegm (mucus)
Ask a cotor or pharmacist before use if your child is
■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers
When using this product
■ do not exceed recommended dosage (see overdose warning)
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ sedatives and tranquilizers may increase the drowsiness effect
Stop use and ask a doctor if
■ nervousness, dizziness, or sleeplessness occur ■ pain, nasal congestion or cough gets worse or lasts more than 5 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
Keep out of reach of children
Overdose section
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms
Directions
■ this product does not contain directions or complete warning for adult use
■ do not give more than directed (see overdose warning)
■ find right dosage on chart below
■ empty each Single-Use Vial of all liquid when dosing, following the instructions under "Easy to use" on the side panel
■ repeat dose every 4 hours while symptoms last
■ do not give more than 5 times in 24 hours
■ children under the age of 6, do not use
Dosing Chart
| Age (Years) | Dose (mL) |
| 6 - 11 years | 1 Single use vial (10mL) every 4 hours. Do not give more than 5 times in 24 hours |
Inactive ingredients
citric acid, edetate disodium, glycerin, maltitol, mixed berry flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate, xanthan gum.
Other information
■ each Single -Use vial contains 11mg of sodium
■ store at 20-25°C (68-77°F)
■ tamper-evident: do not use if the top flap of the box is open. Do not use if any vial is open or broken.
Questions or comments
Call 941-202-3207 or visit www.drkids.com
Package
Products#
Every source-derived product name is available through these pages.
- DrKids Children Multi Symptom Cold and Flu
- Acetaminophen 320mg, Chlorpheniramine maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCl 5mg
- ACETAMINOPHEN
- GLYCERIN
- MALTITOL
- EDETATE DISODIUM
- SORBITOL SOLUTION
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- SODIUM METABISULFITE
- WATER
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- PROPYLENE GLYCOL
- ANHYDROUS CITRIC ACID
- TRISODIUM CITRATE DIHYDRATE
- SODIUM BENZOATE
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73282-0113 | 73282-0113-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1934e296-5ea4-a088-e063-6294a90a8adc | d34957b8-5872-0d79-e053-2a95a90a073f | 2024-05-24 | Warnings | d34957b8-5872-0d79-e053-2a95a90a073f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.